A Study Of Cisplatin (Or Carboplatin) And Etoposide With... | NCT00977561

Label	Type	Description	Intervention Names
Arm A	Experimental	Figitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle	Drug: figitumumab Drug: Cisplatin (Or Carboplatin) Drug: Etoposide
Arm B	Active Comparator	Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle	Drug: Cisplatin (Or Carboplatin) Drug: Etoposide

Name	Type	Description	Arm Group Labels	Other Names
figitumumab	Drug	Figitumumab (20 mg/kg)	Arm A
Cisplatin (Or Carboplatin)

Measure	Description	Time Frame
Progression-Free Survival (PFS)	Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].	Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression

Measure	Description	Time Frame
Number of Participants With Objective Response	Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Washington D.C.	District of Columbia	20007-2197	United States
Pfizer Investigational Site

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 milligram/kilogram (mg/kg) administered intravenously (IV) over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 milligram/square meter (mg/m^2) IV over 1 hour or carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 5 milligram/milliliterminute (mg/mLmin) IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-Free Survival (PFS)

Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].

No analysis of progression-free survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
OG001	Cisplatin or Carboplatin + Etoposide	Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Units	Counts
Participants	OG0000 OG0010

Secondary

Number of Participants With Objective Response

Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.

No analysis of objective response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Secondary

Overall Survival (OS)

Overall survival was the duration from enrollment to death due to any cause. For participants who are alive, overall survival was censored at the last contact. Survival time (days) = [death date (last known alive date) - date of randomization +1].

No analysis of overall survival was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

Every 3 months until death or 12 months from the date the last participant was randomized

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
OG001	Cisplatin or Carboplatin + Etoposide	Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Secondary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject.

All randomized participants who received at least one dose of any agent of the combination were included in the safety analysis.

Posted

Number

participants

Baseline up to follow-up (90 days post dose)

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
OG001	Cisplatin or Carboplatin + Etoposide	Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Secondary

Maximum Observed Plasma Concentration (Cmax) of Figitumumab

No analysis of Cmax for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose

ID	Title	Description
OG000	Figitumumab+ Cisplatin (or Carboplatin) + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Units	Counts
Participants	OG000

Secondary

Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab

No analysis of Cmin for figitumumab was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Units	Counts
Participants	OG000

Secondary

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

No analysis of pharmacokinetics (PK) parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Units	Counts
Participants

Secondary

Maximum Observed Plasma Concentration (Cmax) of Etoposide

No analysis of PK parameters for etoposide was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab

Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab

No analysis of ADA response was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Participants who received figitumumab, whether figitumumab (20 mg/kg, IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles) was given in combination with cisplatin (75 mg/m^2 IV over 1 hour on Day 1 of each cycle) or carboplatin (AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 of each cycle) followed by etoposide (100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle) from the beginning or figitumumab was given as a single agent after documented disease progression with cisplatin (or carboplatin) and etoposide. When given as a single agent, figitumumab was administered as IV infusion on Days 1 and 2 of the initial cycle and on Day 1 of subsequent cycles, up to 17 cycles in the absence of further disease progression or intolerable toxicity. Each cycle was 21 days cycle.

Secondary

Cancer Dyspnea Scale (CDS) Score

The Cancer Dyspnea Scale consists of 12 questions that assess 3 domains of dyspnea (sense of effort, anxiety and discomfort) related to lung cancer. The questions are answered on 5-point Likert scale ranging from 1 to 5 (1 "Not at All" to 5 "Very Much").

No analysis for cancer dyspnea scale score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
OG001	Cisplatin or Carboplatin + Etoposide	Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Secondary

Numeric Rating Scale (NRS) Score

The Numeric Rating Scale (NRS) is a 1-item self-reported questionnaire designed to assess "worst pain" severity. Overall scores range from 0 to 10, with low scores representing a lower level of pain.

No analysis for NRS score was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
OG001	Cisplatin or Carboplatin + Etoposide	Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Secondary

Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway

No analysis of tumor biomarkers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

Baseline prior to dosing

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
OG001	Cisplatin or Carboplatin + Etoposide	Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Secondary

Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers

No analysis for serum circulating IGF pathway related markers was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
OG001	Cisplatin or Carboplatin + Etoposide	Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Secondary

Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs

Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs

No analysis of total CTCs and IGF-IR-expressing CTCs was performed as the study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. As a result, the only endpoint analyzed for the study was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Posted

Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)

ID	Title	Description
OG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
OG001	Cisplatin or Carboplatin + Etoposide	Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0012 affected4 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0002 affected5 at risk EG0010 affected4 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0004 affected5 at risk EG0014 affected4 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0011 affected4 at risk
Deafness	Ear and labyrinth disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Hypothyroidism	Endocrine disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Ocular hyperaemia	Eye disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Visual acuity reduced	Eye disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Constipation	Gastrointestinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0012 affected4 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0011 affected4 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Gingivitis	Gastrointestinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Nausea	Gastrointestinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0003 affected5 at risk EG0014 affected4 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0002 affected5 at risk EG0010 affected4 at risk
Vomiting	Gastrointestinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0012 affected4 at risk
Asthenia	General disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0012 affected4 at risk
Fatigue	General disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0002 affected5 at risk EG0010 affected4 at risk
Feeling cold	General disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Influenza like illness	General disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Infusion site extravasation	General disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Mucosal inflammation	General disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Non-cardiac chest pain	General disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Oedema peripheral	General disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Pyrexia	General disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Candidiasis	Infections and infestations	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0012 affected4 at risk
Otitis media	Infections and infestations	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Urinary tract infection	Infections and infestations	MedDRA (v14.0)	Non-systematic Assessment	EG0002 affected5 at risk EG0010 affected4 at risk
Alanine aminotransferase increased	Investigations	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Blood creatinine increased	Investigations	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Creatinine renal clearance decreased	Investigations	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (v14.0)	Non-systematic Assessment	EG0002 affected5 at risk EG0010 affected4 at risk
Haemoglobin decreased	Investigations	MedDRA (v14.0)	Non-systematic Assessment	EG0002 affected5 at risk EG0010 affected4 at risk
Weight decreased	Investigations	MedDRA (v14.0)	Non-systematic Assessment	EG0002 affected5 at risk EG0011 affected4 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0002 affected5 at risk EG0011 affected4 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0012 affected4 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0011 affected4 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0011 affected4 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0013 affected4 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0011 affected4 at risk
Balance disorder	Nervous system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Convulsion	Nervous system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Dizziness	Nervous system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Dysgeusia	Nervous system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Headache	Nervous system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0011 affected4 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Somnolence	Nervous system disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0002 affected5 at risk EG0010 affected4 at risk
Confusional state	Psychiatric disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Insomnia	Psychiatric disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0002 affected5 at risk EG0011 affected4 at risk
Polyuria	Renal and urinary disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Breast pain	Reproductive system and breast disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0002 affected5 at risk EG0010 affected4 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Nasal ulcer	Respiratory, thoracic and mediastinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Pharyngeal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0003 affected5 at risk EG0012 affected4 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Nail disorder	Skin and subcutaneous tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0010 affected4 at risk
Hypotension	Vascular disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0000 affected5 at risk EG0011 affected4 at risk
Pallor	Vascular disorders	MedDRA (v14.0)	Non-systematic Assessment	EG0001 affected5 at risk EG0011 affected4 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes
D009930	Organic Chemicals
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D011083	Polycyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates

ID	Title	Description
BG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Day 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
BG001	Cisplatin or Carboplatin + Etoposide	Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Figitumumab + Cisplatin or Carboplatin + Etoposide	Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.			4	5	5	5
EG001	Cisplatin or Carboplatin + Etoposide	Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.			2	4	4	4

ID	Term
C525021	figitumumab
D002945	Cisplatin
D016190	Carboplatin
D005047	Etoposide